The opportunityThe main purpose of your job will be to ensure that GxP Computerized Systems and infrastructure implementation and maintenance are managed according to TAPI policies, standards, and procedures.
You will be the IT Business Partner on Computerized Systems Governance to all TAPI sites.
Within this role, you shall maintain effective working relationships with peers within the TAPI Quality and TAPI IT organization.
This position is accountable to ensure that the TAPI QMS related to GxP Computerized System is in constant alignment with current regulations, data integrity principles, industry guidance and inspection trends.
If you are interested to apply, then we would love to see your application in EnglishHow you'll spend your day Continuously improve the TAPI cGxP Computerized Systems policies, standards, procedures, tools and training.
Provide QA IT review and approval on all globally managed Computerized System deliverables For some globally managed Computerized System, represent site users, as System Business owner.
Manage site inspection readiness and support with regards to globally managed Computerized Systems.
Guide TAPI Sites IT and IT QA on inspections trends, observations, authorities' expectations and best practices that can mitigate gaps.
Deliver training programs to TAPI Computerised systems owners.
Support sites with any IT related project(s) as required.
Support sites with computer systems validation, infrastructure qualification and systems life cycle management, together with any remediation needed.
Conduct GxP computerized systems gap assessments/evaluations with applicable regulations Your experience, skills and qualifications Bachelor's degree in Engineering, Computer Science, Science or other related field.
Minimum of 10 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing and laboratory operations Working experience in API/Pharma companies in a similar role is a must.
Proven management capabilities managing direct and matrix teams and projects Strong understanding of regulations and industry standards such as 21 CFR Part-11, Eudralex Annex-11, GAMP 5, Data Integrity regulatory and industry Guidance and proven ability to pragmatically apply these regulations to operate in an efficient and effective fashion.
Exposure, working experience and knowledge of GAMP -5 and SCADA systems Ability to work with external vendors/suppliers, experience with IT supplier management is desirable.
Advanced leadership skills, business strategy, accountability, proven experience leading and motivating global, cross-functional teams.
International experience - a must.
Advanced experience in working with matrix environment.
Advanced negotiation skills.
Advanced knowledge and experience in problem solving.
Advanced communication skills – written and verbal.
Advanced agility leadership and teamwork skills.
Must be able to travel based on business need; up to 30% when critically required (domestic and international).
Fluent in English – a must Pre Employment ScreeningTAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment.
More information on this verification and vetting will be provided if you reach this stage of the application process.
